Pre-Hospital Cooling in Cardiac Arrest Patients (PRE-COOL)

June 5, 2009 updated by: Emergency Medical Service of the Central Bohemian Region, Czech Republic

Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study

Type of study: Pilot prospective nonrandomized feasibility clinical study.

Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in patients successfully resuscitated from out-of-hospital cardiac arrest in the setting of prehospital and hospital care in Czech republic.

Evaluated hypothesis: Pre-hospital initiation of therapeutic mild hypothermia by rapid administration of intravenous bolus of cold crystalloids is simple, safe, effective and is a feasible procedure to significantly decrease body core temperature during patient's transport to the hospital in Czech republic.

The study is observational and does not evaluate any new drug, therapeutic procedure or diagnostic procedure. It is evaluating a known therapeutic procedure, therapeutic mild hypothermia, induced by known technique, cold crystalloid infusion, widely accepted in hospital-related postresuscitative care. However, even its prehospital usage has been published.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
    • Central Bohemian region
      • Beroun, Central Bohemian region, Czech Republic
        • Recruiting
        • Emergency Medical Service of the Central Bohemian Region
        • Contact:
        • Principal Investigator:
          • Roman Skulec, MD
    • Region of Hradec Kralove
      • Hradec Kralove, Region of Hradec Kralove, Czech Republic
        • Recruiting
        • Hradec Kralove Region Emergency Medical Services, Czech republic
        • Contact:
        • Principal Investigator:
          • Anatolij Truhlar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Out-of-hospital cardiac arrest patients

Description

Inclusion Criteria:

  • patients resuscitated from out-of-hospital cardiac arrest
  • remaining comatose and requiring mechanical ventilation

Exclusion Criteria:

  • cardiac arrest of traumatic etiology
  • patient conscious after short cardiopulmonary resuscitation
  • coma of other origin than cardiac arrest (e.g., epileptic paroxysm, intoxication etc.)
  • severe acute heart failure
  • accidental hypothermia below 30°C
  • bradycardia requiring transcutaneous cardiac pacing
  • status Do Not Resuscitate or Do Not Intubate
  • severe circulatory shock
  • severe life threatening cardiac arrhythmias
  • severe and life threatening bleeding
  • severe sepsis
  • any common opinion of intervening team of unfitness of induction of therapeutic mild hypothermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prehospital hypothermia group
All patients included to the study
Procedure: Induction of therapeutic mild hypothermia
Rapid administration of 4°C cold normal saline to the peripheral vein, dose 5 - 30 ml/kg, to decrease body core temperature below 34°C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectivity measure - reached cooling rate calculated in °C/30 min
Time Frame: Assessed during prehospital phase
Assessed during prehospital phase

Secondary Outcome Measures

Outcome Measure
Time Frame
Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia
Time Frame: Assessed during prehospital phase
Assessed during prehospital phase
Achievement of favourable neurological outcome at the hospital discharge
Time Frame: Assessed during prehospital and in-hospital phase
Assessed during prehospital and in-hospital phase
Overall prehospital and in-hospital mortality
Time Frame: Assessed during prehospital and in-hospital phase
Assessed during prehospital and in-hospital phase
The best neurological outcome achieved anytime during hospital stay
Time Frame: Assessed during in-hospital phase
Assessed during in-hospital phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergency Medical Service of the Central Bohemian Region, Czech Republic

Collaborators

University Hospital Hradec Kralove

Investigators

  • Principal Investigator: Roman Skulec, MD, Emergency Medical Service of the Central Bohemian Region, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ANTICIPATED)

July 1, 2009

Study Completion (ANTICIPATED)

August 1, 2009

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (ESTIMATE)

June 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2009

Last Update Submitted That Met QC Criteria

June 5, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCK-KVK-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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